Katsinelos P, Paroutoglou G, Chatzimavroudis G, Terzoudis S, Zavos C, Gelas G, Pilpilidis I, Kountouras Jannis
Department of Endoscopy and Motility Unit, G. Gennimatas General Hospital, Thessaloniki, Greece.
Acta Gastroenterol Belg. 2010 Oct-Dec;73(4):445-50.
This prospective randomized study compared the patency and effective drainage rate of two stents with different materials but similar design, in the palliation of inoperable malignant biliary obstruction.
A total of 49 patients (26 women, mean age 72.55 +/- 10.75 years, range: 48-91 years) with obstructive jaundice due to inoperable malignant stricture of the distal common bile duct without previous drainage procedure, were randomly assigned to receive 10F Double Layer (DLS) (n = 24) or 10F Tannenbaum (TAN) (n = 25) biliary plastic stent. The diagnosis included pancreatic cancer (n = 33), cholangiocarcinoma (n = 8), ampullary cancer (n = 7) and metastatic lymphadenopathy (n = 1). The duration of stent patency, the effective drainage, and the adverse events were analyzed.
Stent placement was successful in all patients with minor complications. The overall median patency rates between the two groups did not differ (107.5 days for DLS group vs. 101 days for TAN group ; p = 0.066). Effective drainage rate at the end of second week was 95.8% for DLS group and 96% for TAN group, (p = 1.00). Proximal stent migration occurred in one patient with TAN stent.
The present study demonstrated that both DLS and TAN stents are comparable in terms of placement, overall stent patency, and complications.
本前瞻性随机研究比较了两种材料不同但设计相似的支架在缓解不可切除恶性胆管梗阻方面的通畅率和有效引流率。
共有49例患者（26例女性，平均年龄72.55±10.75岁，范围：48 - 91岁）因远端胆总管不可切除恶性狭窄导致梗阻性黄疸且此前未进行过引流手术，被随机分配接受10F双层（DLS）（n = 24）或10F坦嫩鲍姆（TAN）（n = 25）胆道塑料支架。诊断包括胰腺癌（n = 33）、胆管癌（n = 8）、壶腹癌（n = 7）和转移性淋巴结病（n = 1）。分析了支架通畅持续时间、有效引流情况及不良事件。
所有患者支架置入均成功，并发症轻微。两组的总体中位通畅率无差异（DLS组为107.5天，TAN组为101天；p = 0.066）。第二周结束时，DLS组的有效引流率为95.8%，TAN组为96%，（p = 1.00）。1例使用TAN支架的患者发生近端支架移位。
本研究表明，DLS和TAN支架在置入、总体支架通畅率及并发症方面具有可比性。
